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Medical Device News – FDA forms partnership to advance development of Covid-19 diagnostics

Medical Device News – FDA forms partnership to advance development of Covid-19 diagnostics

The US Food and Drug Administration (FDA) is collaborating with the Reagan-Udall Foundation and Friends of Cancer Research for a project called Covid-19 Diagnostics Evidence Accelerator.


The project aims to enhance the development of coronavirus diagnostics. It will enable experts in health data to analyse diagnostic and clinical data in real-time and analyse what data may reveal about the prevalence of the disease, chains of transmission and individual and population-level immunity.


Additionally, the project seeks to determine if the presence of antibodies can indicate future immunity and to evaluate the specific antibodies and epitopes that contribute to protection against future infection.


The accelerator is the companion project to the previously announced Therapeutic Evidence Accelerator for comparing results and answering key questions to inform the collective Covid-19 response.

FDA principal deputy commissioner Amy Abernethy was quoted by The Cancer Letter as saying: “While there are current studies of viral diagnostic and antibody tests, using traditional assessment methods, the Diagnostics Evidence Accelerator will allow the community to analyse both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for Covid-19.


“FDA’s participation in the Diagnostics Evidence Accelerator is another example of how we are working with a broad set of experts in healthcare data and analytics to understand the performance of SARS-CoV-2 tests and to inform clinical and public health decision-making.”


The evidence generated through the Diagnostics Accelerator will be complementary to other studies that have been conducted or are underway.…